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Testing Begins for RELIEV-CM2 Study of ShiraTronics Neuromodulation Device in Chronic Migraine
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Key Takeaways
- RELIEV-CM2 trial evaluates a neuromodulation device for chronic migraine across the U.S. and Australia.
- The study includes four phases: assessment, trial, implant, and follow-up, targeting specific migraine criteria.
Early data from the pilot RELIEV-CM trial showed significant reductions in headache and migraine days, with 56% of patients showing a 50% reduction in symptoms at 4 weeks, and 100% at 12 weeks.
Sandeep Vaid, MD
According to a new announcement from ShiraTronics, the company has successfully launched its RELIEV-CM2 study, with the first successful implants in patients with chronic migraine (CM). The study, an FDA-approved investigation device exemption pivotal trial spanning across the United States and Australia, tests the therapeutic effects of the company’s neuromodulation device placed under the skin and arms.1
The study remains still enrolling, looking for patients who are at least 22 years of age, who’ve had migraine for at least 12 months, experience at least 15 or more headache days per month, and have episodes lasting more than 4 hours. Coming into the study, patients must have no prior treatment with a neurostimulator and no onabotulinumtoxinA injections for purposes other than managing migraine within the last 6 months.
The RELIEV-CM2 study consists of four phases: the Assessment Phase, where participants complete a 28-day headache diary to determine eligibility; the Trial Phase, where temporary leads are inserted to test the therapy; the Implant Phase, involving a minimally invasive procedure to place permanent stimulators; and the Use & Follow-Up Phase, where the therapy is used continuously, with regular check-ups and system charging.
"Bringing this new therapy to patients represents an exciting step forward in migraine management. Chronic Migraine has a profound impact on people's lives, limiting daily activities and affecting overall well-being," trial investigator Sandeep Vaid, MD, medical director of Clinical Research at Vista Clinical Research in Newnan, Georgia, said in a statement.1 "This device offers a fresh approach that, based on early results, holds promise for improving how patients function day-to-day. It's a privilege to be part of this pivotal study and witness what this technology might mean for patients who have exhausted other options."
READ MORE: Sumatriptan Demonstrates Therapeutic Potential in Post-Traumatic Headache in Phase 2 Pilot Study
RELIEVE-CM2 builds on positive findings from a previously completed pilot trial, RELIEV-CM, which featured a small cohort of 10 patients with CM. Overall, the neurostimulation device was considered well tolerated, with 28 adverse events (AEs) recorded and no serious AEs observed. In the findings, presented at the American Headache Society conference in June, all AEs observed in the study quickly and spontaneously resolved.2
In terms of efficacy, data from RELIEV-CM showed that treatment with the device resulted in significant and clinically meaningful reductions in both mean headache (8.3) and migraine (8.3) days after 4 weeks. After 12 weeks of treatment, investigators recorded reductions in monthly headache days (MHDs) and monthly migraine days (MMDs) of 14.4 and 13.5 days/month, respectively. Notably, most of this patient population had previously not responded to or stopped taking multiple classes of oral or injectable therapeutics including botulinum toxin and calcitonin gene-related peptide (CGRP) monoclonal antibodies/receptor blockers.
Additional data from the study showed that responder rates—considered a 50% reduction in MHD or MMD—were 56% at 4 weeks and 100% at 12 weeks for both MHD and MMD. In addition, headache severity was significantly reduced at 4 and 12 weeks following implantation and therapy, with similar improvements seen in secondary outcomes such as Migraine Specific Quality of Life (MSQ) and Migraine Disability Assessment (MIDAS) scores.
"The minimally invasive nature of this procedure allows us to implant the device efficiently, making the procedure easily adopted by implanting physicians,” Marc Russo, MD, immediate past-president of the International Neuromodulation Society, said in a statement.1 "The initial results we've seen have been very promising, and the procedure itself has been both straightforward and well-received by patients. I'm honored to contribute to the development of a therapy that could offer sustainable benefits for those living with persistent, treatment-resistant migraines."
